FDA approves the TM-S Trabecular Metal Cervical Interbody Fusion device


The US FDA has approved the TM-S Trabecular Metal Cervical Interbody Fusion device  produced by Zimmer Holdings. The TM-S system is the industry’s first cervical interbody device incorporating porous metal technology, and the first Zimmer Trabecular Metal device for cervical interbody fusion in the United States.

The TM-S system is constructed from Zimmer’s proprietary Trabecular Metal technology, a unique porous metal biomaterial with structural and mechanical properties similar to cancellous bone. Trabecular Metal material provides an osteoconductive scaffold which supports bony in-growth and vascularisation into the implant. Utilised in cervical interbody fusion, the properties of this material provide an excellent environment for bone growth.

“With the introduction of the TM-S system, Zimmer is bringing the potential benefits of porous metal technology to cervical interbody fusion,” said Steve Healy, president, Zimmer Spine. “The osteoconductive properties of Trabecular Metal Technology support initial fixation and can potentially aid in cervical fusion.”

The TM-S Cervical Fusion device is intended for use with supplemental fixation systems and with autogenous bone graft. The device is designed to treat the cervical spine of patients with degenerative disc disease with or without radicular symptoms at one level from C2−T1.

This novel device will be on display at the 2011 American Academy of Orthopaedic Surgeons (AAOS) annual meeting. Zimmer Spine will also be hosting hands-on training for the device at the company’s exhibit at AAOS 2011.